BiocurePharm, Korea (“BPK”) Announces Closing of Convertible Debenture Financing

On December 5, 2019 BiocurePharm, Korea ("BPK"), a wholly owned subsidiary of Biocure Technology Corp. (CSE: CURE) (OTCQB: BICTF) ("CURE" or the "Company") reported that it has closed its Convertible Debenture financing. BPK has issued convertible debentures for gross proceeds of Korean Won660,000,000 (CAD732,600) (Press release, Biocure Technology, DEC 5, 2019, View Source [SID1234628753]). Its maturity date is December 5, 2029, with the coupon rate of 3%. The investor has a right to convert to common shares of BPK at CAD12.21 per share three years after the issuance of Convertible Debenture. All dollar values are based on the published Exchange Rate of CAD0.001110/KRW1 on December 4, 2019, Bank of Canada.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Abbisko Therapeutics Announces the IND Approval of a Novel FGFR4 Inhibitor ABSK011 by the Taiwan FDA

On December 5, 2019 Abbisko Therapeutics, a clinical-stage biopharmaceutical company, reported that it has received the regulatory approval from the Taiwan FDA to initiate Phase 1 clinical trials for ABSK011, a fibroblast growth factor receptor 4 (FGFR4) inhibitor, in patients with hepatocellular carcinoma (HCC) (Press release, Abbisko Therapeutics, DEC 5, 2019, View Source;article_id=134 [SID1234556286]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FGFRs, belonging to tyrosine receptor kinase family, comprise four subtypes (FGFR1-4), and their activation play critical roles in cell growth, proliferation, survival and metastasis in multiple advanced tumors. Aberrant activation of FGFR4 signaling pathway is frequently observed in HCC. Blocking its activities represents a potential therapeutic approach for HCC treatment. HCC is one of the most common types of malignant tumors with high prevalence in Asia and strong unmet clinical need. At present, there are no FGFR4-targeted therapeutic drugs available on the market worldwide.

ABSK011 was independently discovered and developed by Abbiskso Therapeutics with global intellectual property rights. It is an orally available, highly potent and selective small molecule inhibitor of FGFR4 with best-in-class potential.

Founded in April 2016, Abbisko Therapeutics Co., Ltd. is a biopharmaceutical company dedicated to discovering and developing innovative therapeutics to treat cancer and other diseases with unmet medical needs. The founders and core team of Abbisko are industrial veterans with strong leadership and managerial experiences from top international pharmaceutical companies. In three years, Abbisko has established a strong oncology pipeline with multiple programs entering the clinic.

Mogrify wins Innovation Award and Dr. Jane Osbourn, OBE receives Lifetime Achievement Award at Scrip Awards 2019

On December 5, 2019 Mogrify Ltd (Mogrify), a UK company aiming to transform the development of cell therapies, reported that it received MSD’s Innovation Award at the 15th Annual Scrip Awards, and the Lifetime Achievement Award was presented to Dr. Jane Osbourn, OBE, Chair at Mogrify (Press release, Mogrify, DEC 5, 2019, View Source [SID1234553997]). The Innovation Award recognizes the significant potential the Company’s direct cellular conversion technology has to disrupt the future development of new medicines. Dr. Osbourn received the Lifetime Achievement Award in recognition of her outstanding contribution to the biotech industry throughout her career.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Mogrify has developed a proprietary direct cellular conversion technology, which makes it possible to transform any human cell type into any other, without going through a pluripotent stem cell- or progenitor cell-state. The Company is using this platform to produce cell types with unrivaled safety, efficacy and scalable manufacturing profiles that can be used to develop novel cell therapies addressing musculoskeletal, auto-immune, cancer immunotherapy, ocular and respiratory diseases.

Dr. Osbourn is a scientific leader in the field of antibody engineering with more than 30 years of experience in biologics discovery and development. During this time she has been Vice President for Research and Development and Site Leader at MedImmune (AstraZeneca), formerly Cambridge Antibody Technology (CAT), Chair of the Board of Directors of the BioIndustry Association, a Director of Babraham Bioscience Technologies, and a Director of Cambridge Enterprise. She has made significant contributions to the discovery and development of phage display technology, eight marketed drugs (including HUMIRA and BENLYSTA) and over 40 clinical candidates. Dr. Osbourn holds a doctorate from the John Innes Institute in Norwich, UK and a first-class degree in natural sciences from the University of Cambridge, and was awarded an OBE for services to drug discovery, development and biotechnology.

The Scrip Awards seek to applaud the role that the pharmaceutical, biotech and other allied industries play in improving healthcare. Its trophies span a range of industry activities, from new drug launches and clinical trials, to innovative deals, outsourcing and fundraising. This year’s new category, MSD’s Innovation Award, acknowledges and celebrates the outstanding scientific or technological breakthroughs that have the potential to be transformative in the discovery or development of new medicines. Scrip’s Lifetime Achievement Award is presented to individuals who have had a distinguished career in the biotech or pharmaceutical arena, primarily within industry with a consistent history of exceptional service, throughout their career.

Dr. Darrin M. Disley, OBE, CEO, Mogrify, said: "Our systematic approach to the discovery of novel cell conversions has the potential to transform cell therapy. Mogrify’s technology opens up the opportunity to develop and scale up any autologous and allogeneic cell therapies, as well as create a new class of therapies: in vivo reprograming and could therefore have a significant impact on the treatment of degenerative conditions and cancers. We are proud to have our innovative platform and pioneering approach recognized by the judges.

Dr. Osbourn has contributed significantly to the industry throughout her impressive career and is globally renowned for her expertise in biologics discovery and development. She is an inspirational leader and we look forward to celebrating her exceptional achievements."

Dr. Jane Osbourn, OBE, Chair, Mogrify, said "I am honored to have received the Lifetime Achievement Award. Throughout my career I have been fortunate to have worked with many pioneering scientists, who have helped us achieve success in biologics discovery and development. Working together in a diverse team is vital if we are to build great culture and drive innovation. I would like to thank all the extraordinary people who have supported me and I hope to continue to foster many more successful collaborations."

Prof. Jose Polo, CMO (Co-founder) and Prof. Julian Gough, CSO (Co-founder) were presented with the Innovation Award at the prestigious ceremony, which took place in at the London Hilton on Park Lane in Mayfair on 4 December.

Y-mAbs and the European Medicines Agency Pediatric Committee Reach Agreement on the Pediatric Investigation Plan for Omburtamab

On December 5, 2019 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the European Medicines Agency ("EMA") has agreed to the Company’s proposed Pediatric Investigation Plan ("PIP") for omburtamab (Press release, Y-mAbs Therapeutics, DEC 5, 2019, View Source [SID1234551989]). The decision was made on the basis of a positive opinion from EMA’s Pediatric Committee ("PDCO"). Omburtamab is being developed by Y-mAbs for the treatment of CNS/leptomeningeal metastases from neuroblastoma which is the indication targeted by the PIP, as well as a number of additional cancer indications.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. An approved PIP is a prerequisite for filing a Marketing Authorization Application ("MAA") for any new medicinal product in Europe.

"We are pleased to announce this important regulatory milestone. The approval of the PIP provides Y-mAbs with a clear path for registration of omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma. We look forward to continuing to work with EMA and PDCO to bring this important therapy to the European market as soon as possible," said Thomas Gad, Founder, Chairman, President and Head of Business Development and Strategy.

Dr. Claus Moller, Chief Executive Officer further notes, "We are preparing the European submission of the marketing authorization application for omburtamab, and plan for submission in the second half of 2020. This is a vital step forward in our efforts of bringing omburtamab to the market in Europe, and it demonstrates the close and constructive interactions established with the regulatory authorities in Europe.

Researchers at Memorial Sloan Kettering ("MSK") developed the therapeutic product referenced in this statement, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product and in Y-mAbs.

ARTIDIS Gains Strong Momentum in 2019, Raising CHF 8.8 Million in Seed Financing

On December 5, 2019 ARTIDIS reported a privately held healthtech company, announced today the successful closure of a CHF 8.8 million seed financing in two rounds, securing early clinical validation and the next development phase towards market entry in 2021 (Press release, ARTIDIS, DEC 5, 2019, View Source;raising-chf-8-8-million-in-seed-financing-300969365.html [SID1234551988]). The funding will be used to advance the company’s healthtech platform into a large multi-centre clinical study together with the University Hospital Tuebingen (Germany), University Hospital Barcelona (Spain), and Texas Medical Center (Houston, US). The study aims to further validate the value of ARTIDIS in diagnosing breast and lung cancer, as well as for personalizing and optimizing cancer treatment. The results will support the regulatory submissions to the FDA and the European Notified Body to gain approval for the ARTIDIS medical device and data platform. This is one of the major prerequisites for ARTIDIS to enter the diagnostic market world-wide in 2021 in order to improve the standard of care for cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Marija Plodinec, CEO of ARTIDIS commented: "The closure of this financing round and the successful recruitment of 545 patients in our first clinical study at the University Hospital Basel this year is a huge success. We are thankful for the support and trust of all our shareholders – together, we are opening a new chapter towards personalizing the patient journey."

The round was supported by family offices and private individuals from Switzerland and the EU, including BERNINA Bioinvest, Zurich and SMD MedicalTrade AG, Taegerwilen.

"We are extremely happy for the opportunity to invest in this promising company and support the great team of ARTIDIS on their mission to deliver fast diagnosis and personalized treatment to cancer patients," stated Philipp Looser from SMD Medical Trade AG.

The management of BERNINA BioInvest commented: "ARTIDIS brings the future of cancer diagnostics and treatment to the patients and clinicians. We support ARTIDIS because their approach will significantly optimize the diagnostics workflow and has the potential to revolutionize the way treatment decision-making is done, improving not only the personal patient journey but benefiting the whole healthcare ecosystem. We are confident that Marija Plodinec and her team have the expertise, the passion, and the drive needed to realize this vision."

Martin Gertsch, Chairman of the Board says: "We are very glad that we could also strengthen our Board of Directors during this year: Owing to their significant industry experience and diverse subject matter expertise, Ms Trudi Haemmerli, Board Member Innosuisse, and Dr. Reinhard Ambros, former Global Head of Novartis Venture Fund, were both elected as Board of Directors this year."